New lung cancer cocktail aims to outperform current standard in phase 3 trial

NCT ID NCT05687266

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study is testing whether a combination of three drugs—datopotamab deruxtecan (Dato-DXd), durvalumab, and carboplatin—works better than the current standard treatment (pembrolizumab plus chemotherapy) for people with advanced non-small cell lung cancer that does not have certain genetic mutations. About 1,350 adults with stage IIIB, IIIC, or IV NSCLC are taking part globally. The main goals are to see if the new combo delays cancer progression and improves survival, especially in patients whose tumors have a specific biomarker called TROP2.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Datopotamab deruxtecan (Dato-DXd), durvalumab, carboplatin, pembrolizumab, cisplatin
What this could lead to: If successful, this could offer a new first-line treatment option for advanced lung cancer patients who don't have certain genetic mutations, potentially improving how long they live without their cancer growing.
What could go wrong: This is a large Phase 3 trial, but it's still experimental. The new combination may not prove better than the current standard treatment, and side effects from the drug combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,350 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion: * Participants ≥ 18 years at screening * Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease * Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations). Testing is not required for tumors with squamous histology, with exceptions. * ECOG PS of 0 or 1 * Archival tumour tissue * Has adequate bone marrow reserve and organ function within 7 days before randomization Exclusion: * Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC * History of another primary malignancy with exceptions * Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1 or baseline, with exceptions. * Spinal cord compression or clinically or radiologically active brain metastases * History of leptomeningeal carcinomatosis. * Known active or uncontrolled hepatitis B or C virus infection. * Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals. * Clinically significant corneal disease * History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NSCLC

Contacts and locations

Locations

Research Site

Phoenix, Arizona, 85054, United States
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Tucson, Arizona, 85704, United States
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Hot Springs, Arkansas, 71913, United States
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Little Rock, Arkansas, 72205, United States
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Springdale, Arkansas, 72762, United States
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Fountain Valley, California, 92708, United States
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Los Angeles, California, 90017, United States
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Orange, California, 92868, United States
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Boulder, Colorado, 80303, United States
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Fort Myers, Florida, 33901, United States
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Jacksonville, Florida, 32224, United States
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St. Petersburg, Florida, 33705, United States
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West Palm Beach, Florida, 33401, United States
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Hinsdale, Illinois, 60521, United States
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Fort Wayne, Indiana, 46845, United States
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Bettendorf, Iowa, 52722, United States
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Iowa City, Iowa, 52242, United States
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Waukee, Iowa, 50263, United States
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Baton Rouge, Louisiana, 70808, United States
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Covington, Louisiana, 70433, United States
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Duluth, Minnesota, 55805, United States
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Rochester, Minnesota, 55905, United States
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Hannibal, Missouri, 63401, United States
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Lincoln, Nebraska, 68506, United States
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Lincoln, Nebraska, 68516, United States
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Clifton Park, New York, 12065, United States
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Asheville, North Carolina, 28806, United States
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Canton, Ohio, 44710, United States
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Columbus, Ohio, 43219, United States
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Maumee, Ohio, 43537, United States
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Tulsa, Oklahoma, 74134, United States
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Portland, Oregon, 97239, United States
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Salem, Oregon, 97301, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19111, United States
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York, Pennsylvania, 17403, United States
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Watertown, South Dakota, 57201, United States
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Memphis, Tennessee, 38120, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77090, United States
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Irving, Texas, 75063, United States
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Fairfax, Virginia, 22031, United States
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Henrico, Virginia, 23229, United States
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Norfolk, Virginia, 23502, United States
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Renton, Washington, 98055, United States
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Spokane, Washington, 99202, United States
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Tacoma, Washington, 98405, United States
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Appleton, Wisconsin, 54911, United States
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La Crosse, Wisconsin, 54601, United States
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Graz, 8036, Austria
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Rankweil, 6830, Austria
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Vienna, 1090, Austria
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Vienna, 1210, Austria
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Blumenau, 89010-340, Brazil
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Florianópolis, 88034-000, Brazil
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Fortaleza, 60336-045, Brazil
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Londrina, 86015-520, Brazil
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Porto Alegre, 90035-903, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 01509-900, Brazil
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São Paulo, 09323-900, Brazil
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Taubaté, 12030-200, Brazil
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Vitória, 29043-260, Brazil
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Sofia, 1113, Bulgaria
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Sofia, 1330, Bulgaria
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Varna, 9010, Bulgaria
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Saint John, New Brunswick, E2L 4L2, Canada
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Brampton, Ontario, L6R 3J7, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Saint-Jérôme, Quebec, J7Z 5T3, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Beijing, 100010, China
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Beijing, 100029, China
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Beijing, 100037, China
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Beijing, 100039, China
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Beijing, 100853, China
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Beijing, CN-100730, China
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Changsha, 410008, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400037, China
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Guangzhou, 510000, China
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Guangzhou, 510100, China
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Hefei, 230601, China
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Jinan, 250021, China
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Kunming, 650101, China
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Lanzhou, 730000, China
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Liuzhou, 545006, China
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Shandong, China
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Shanghai, 200030, China
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Shanghai, 200032, China
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Shanghai, 200080, China
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Shantou, 515041, China
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Shenyang, 110004, China
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Shenzhen, 517108, China
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Taiyuan, 030000, China
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Tianjin, 300060, China
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Wenzhou, 325000, China
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Wuhan, 430030, China
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Wuhan, 430060, China
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Xiamen, 361004, China
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Yangzhou, 225001, China
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Zhengzhou, 450052, China
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Brest, 29200, France
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Créteil, 94010, France
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Gleizé, 69400, France
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Montpellier, 34070, France
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Nîmes, 30029, France
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Paris, 75018, France
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Paris, 75674, France
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Rouen, 76031, France
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Saint-Quentin, 02321, France
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Strasbourg, 67091, France
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Toulon, 83800, France
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Toulouse, 31059, France
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Tours, 37000, France
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Bad Berka, 99437, Germany
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Berlin, 14109, Germany
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Frankfurt A. Main, 60590, Germany
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Gauting, 82131, Germany
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Gütersloh, 33332, Germany
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Hamburg, 20251, Germany
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Kassel, 34125, Germany
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Kiel, 24116, Germany
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Koblenz, 56073, Germany
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Minden, 32429, Germany
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Rosenheim, 83022, Germany
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Velbert, 42551, Germany
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Würzburg, 97074, Germany
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Athens, 11526, Greece
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Athens, 11527, Greece
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Athens, 155 62, Greece
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Piraeus, 185 47, Greece
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Thessaloniki, 55236, Greece
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Thessaloniki, 57001, Greece
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Budapest, 1121, Hungary
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Budapest, 1122, Hungary
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Gyöngyös - Mátraháza, 3200, Hungary
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Kaposvár, 7400, Hungary
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Pécs, 7624, Hungary
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Szekszárd, 7100, Hungary
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Szolnok, 5000, Hungary
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Törökbálint, 2045, Hungary
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Calicut, 673601, India
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Delhi, 110029, India
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Delhi, 110085, India
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Jaipur, 302017, India
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Kolkata, 700160, India
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Madurai, 625107, India
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Puducherry, 605006, India
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Florence, 50134, Italy
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Lecco, 23900, Italy
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Messina, 98158, Italy
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Naples, 80131, Italy
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Orbassano, 10043, Italy
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Padova, 35128, Italy
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Parma, 43126, Italy
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Peschiera del Garda, 37019, Italy
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Rozzano, 20089, Italy
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Hamamatsu, 431-3192, Japan
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Hamamatsu, 432-8580, Japan
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Hidaka-shi, 350-1298, Japan
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Hirosaki-shi, 036-8563, Japan
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Hiroshima, 730-8518, Japan
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Kumamoto, 860-8556, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 466-8560, Japan
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Okayama, 700-8558, Japan
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Osaka, 545-8586, Japan
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Osakasayama-shi, 589-8511, Japan
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Sapporo, 060-8638, Japan
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Sunto-gun, 411-8777, Japan
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Wakayama, 641-8510, Japan
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Yokohama, 221-0855, Japan
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Yokohama, 241-8515, Japan
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Del. Cuauhtemoc, 06700, Mexico
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Mexico City, 03810, Mexico
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México, 14080, Mexico
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San Luis Potosí City, 78209, Mexico
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Arequipa, 04002, Peru
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Concepción, 12125, Peru
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Lima, 15036, Peru
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Lima, 34, Peru
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Lima, LIMA 27, Peru
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Lima, LIMA 29, Peru
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Bydgoszcz, 85-796, Poland
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Bystra, 43-360, Poland
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Grudziądz, 86-300, Poland
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Kielce, 25-734, Poland
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Koszalin, 75-581, Poland
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Olsztyn, 10-357, Poland
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Poznan, 60-569, Poland
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Przemyśl, 37-700, Poland
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Racibórz, 47-400, Poland
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Radom, 26-600, Poland
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Siedlce, 08-110, Poland
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Busan, 48108, South Korea
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Cheongju-si, 28644, South Korea
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Jinju, 52727, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 07061, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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Las Palmas de Gran Canaria, 35016, Spain
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Lugo, 27003, Spain
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Madrid, 28041, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Zaragoza, 50009, Spain
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Gävle, 801 88, Sweden
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Linköping, 581 85, Sweden
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Lund, 221 85, Sweden
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Stockholm, 17176, Sweden
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Uppsala, 751 85, Sweden
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Hsinchu, 300, Taiwan
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New Taipei City, 235, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 73657, Taiwan
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Taipei, 11217, Taiwan
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Taoyuan, 333, Taiwan
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Adana, 01060, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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Aberdeen, AB25 2ZN, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Cheltenham, GL53 7AN, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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London, SE1 9RT, United Kingdom
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London, W6 8RF, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Hanoi, 100000, Vietnam
Research Site

Ho Chi Minh City, 700000, Vietnam

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